Carprieve 20 mg Tablets for Dogs

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Preparatomtale Preparatomtale (SPC)
26-06-2019
DSU DSU (DSU)
25-07-2023

Aktiv ingrediens:

Carprofen

Tilgjengelig fra:

Norbrook Laboratories (Ireland) Limited

ATC-kode:

QM01AE91

INN (International Name):

Carprofen

Dosering :

20 mg/tablet

Legemiddelform:

Tablet

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

carprofen

Autorisasjon status:

Authorised

Autorisasjon dato:

2003-07-25

Preparatomtale

                                Health Products Regulatory Authority
25 June 2019
CRN0094PM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Carprieve 20 mg Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
_ACTIVE SUBSTANCE:_
Carprofen 20 mg
_EXCIPIENTS:_
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets:
A white/off white circular tablet with a break line on one face and
“20” scored on the opposing face.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For analgesia and reduction of chronic inflammation in musculoskeletal
disturbances in dogs, for example in degenerative joint
disease.
4.3 CONTRAINDICATIONS
Use of this product in cats is contra-indicated.
Do not use in dogs suffering from cardiac, hepatic or renal disease,
where there is a possibility of gastrointestinal ulceration or
bleeding, or where there is evidence of a blood dyscrasia or
hypersensitivity to the product.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Refer to statements under Sections 4.3 and 4.5
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Use in dogs less than 6 weeks of age, or in aged animals, may involve
additional risk. If such use cannot be avoided, such dogs
may require a reduced dosage and careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there
is a potential risk of increased renal toxicity.
NSAIDs can cause inhibition of phagocytosis and hence in the treatment
of inflammatory conditions associated with bacterial
infection, appropriate concurrent antimicrobial therapy should be
instigated.
Health Products Regulatory Authority
25 June 2019
CRN0094PM
Page 2 of 4
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS:
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Typical undesirable effects associated with NSAIDs, such as vomiting,
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